Cochlear Implants
by Cochlear Guest Author

Science Spotlight: Speech perception and QoL effectiveness CI in a group of adults 65 years or older

January 19, 2021
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Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older

A Secondary Analysis of a Nonrandomized Clinical Trial

Wick CC, Kallogjeri D, McJunkin JL, et al

Assessment of Cochlear Implants for Adult Medicare Beneficiaries Aged 65 Years or Older Who Meet Expanded Indications of Open-Set Sentence Recognition

A Multicenter Nonrandomized Clinical Trial

Zwolan TA, Kallogjeri D, Firszt JB, Buchman CA

Purpose

To explore speech perception and quality-of-life (QoL) effectiveness of cochlear implants (CI) in a group of adults 65 years or older compared with an optimized bilateral hearing aid (HA) condition, and to examine the improvement on the AzBio Sentence Test for Medicare beneficiaries who meet the expanded criteria of a score of 41% – 60% in the best-aided condition.

Key messages

Cochlear implantation is a safe and effective treatment for hearing loss in adults age 65+ who meet both traditional1 and expanded2 Medicare guidelines. Results show significant and meaningful improvements in speech perception and quality-of-life, without an elevated risk profile in this population.

Methods

Wick et al.

  • Non-randomized controlled trial, multicenter, prospective, repeated measures design
  • 13 clinical sites
  • 70 subjects age 65 years and older with postlinguistic onset of bilateral moderate sloping to profound sensorineural hearing loss with an aided CNC word score of ≤40% in the ear to be implanted and ≤50% in the contralateral ear. Note that Wick et al. is a secondary analysis of subjects age ≥65yrs who are part of the larger dataset found in Buchman et al.

All subjects were experienced users of hearing aids and completed objective speech perception testing and subjective QoL surveys prior to implantation. All enrolled subjects were implanted with a CI532 electrode and used a Nucleus® 7 Sound Processor on the implanted ear and a new ReSound hearing aid on the contralateral ear. Subjects were seen by their clinicians at 1m, 3m, 6m and 12m post-activation, with endpoint measurements collected at the 6m visit. Subjects also completed a post-operative high-resolution CT scan to confirm electrode placement.

Zwolan et al.

  • Non-randomized, multicenter, prospective clinical trial
  • 8 clinical sites
  • 34 subjects age 65+ years with bilateral moderate to profound hearing loss and best-aided pre-operative AzBio Sentence Test scores of 41-60%. Note that the current CMS criteria require a score of 40% or poorer.

The study examined speech recognition, telephone communication, hearing device benefit, health utility and quality-of-life in a group of Medicare beneficiaries. Assessments were performed pre-operatively, and at 6m and 12m post-cochlear implantation.  

Results

Wick and colleagues found that CIs provided meaningful improvement in speech perception and QoL in a population of 70 subjects who were age 65+ years at the time of implantation. The subjects demonstrated an estimated marginal mean (EMM) improvement in CNC words scores of 44.1% in the implanted ear alone, and 32.7% in the bimodal condition (CI+HA). Individually, 83% of subjects showed an improvement of 15% or more in the bimodal condition. On AzBio Sentences at +10dB SNR, the EMM score improved by 24.5% in the implanted ear alone and by 21.6% in the bimodal condition (Figure 1).

The Total score on the Speech, Spatial, and Qualities of Sound survey (SSQ49) improved from a baseline score of 2.04 to score 4.97 at 6 months post-CI – a difference of 2.93 points on a 10-point scale. On the Health Utilities Index (possible score range of 0-1.0), the average pre-operative hearing score was low (0.298 with bilateral HAs) and increased to 0.605 after 6 months of using a CI and HA together (change of 0.307). At this 6-month endpoint, 94% of the subjects reported that they were satisfied with their everyday listening condition, compared with only 9% of subjects who were satisfied pre-operatively when using two well-fit HAs.

In addition to the objective and subjective benefit of CI seen in this cohort, the surgery was generally well tolerated with no major adverse events within these first six months. All reported adverse events were minor, and typically associated with a CI, suggesting that this age group of recipients do not seem to present at higher risk for complication when comorbidities are appreciated and managed pre-operatively.

In agreement with the Wick article, Zwolan et al. reported similar speech perception benefits in a group of 31 subjects age 65+ years. The group in this study is further defined by their pre-operative scores of 41-60% on AzBio sentences which is better than the currently approved Medicare guideline. On CNC words, the EMM increased by 43% in the implanted ear alone, and by 36.5% in the best aided condition at six months post-implantation. On AzBio Sentences in quiet, the group demonstrated an EMM increase of 42.4% in the CI alone condition and 32.3% in the best-aided condition (Figure 2). The subjects’ reports of perceived hearing and health benefit also reflected significant and clinically meaningful improvement after receiving a CI.

Conclusions

The results of these two clinical trials of participants ≥ 65 years found clinically important speech understanding improvements in quiet and noise, and notable QoL and hearing satisfaction benefits when using a CI or a CI+HA versus using bilateral HAs. The advantages were seen in subjects who meet the current CMS indication for cochlear implantation, as well as in those who exceed it by as much as 20%. Complications and adverse events were neither major nor prolonged, indicating the risk/benefit profile to be acceptable for this age group. These findings suggest that cochlear implantation in older adults could be extended to those with better pre-operative speech understanding and could contribute to a healthy aging process.

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References

Buchman CA, Herzog JA, McJunkin JL, et al. Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. Published online August 27, 2020. doi:10.1001/jamaoto.2020.1584

Citation:

  1. Wick CC, Kallogjeri D, McJunkin JL, et al. Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older: A Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. Published online August 27, 2020. doi:10.1001/jamaoto.2020.1585
  2. Zwolan TA, Kallogjeri D, Firszt JB, Buchman CA. Assessment of Cochlear Implants for Adult Medicare Beneficiaries Aged 65 Years or Older Who Meet Expanded Indications of Open-Set Sentence Recognition: A Multicenter Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. Published online August 27, 2020. doi:10.1001/jamaoto.2020.2286

Authors & Affiliations:

Department of Otolaryngology–Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri

Cameron C. Wick, MD (1)

Dorina Kallogjeri, MD, MPH (1,2)

Jonathan L. McJunkin, MD (1)

Nedim Durakovic, MD (1)

Laura K. Holden, AuD (1)

Jacques A. Herzog, MD (1)

Jill B. Firszt, PhD (1,2)

Craig A. Buchman, MD (1,2)

Statistics Editor, JAMA Otolaryngology–Head & Neck Surgery

Dorina Kallogjeri, MD, MPH (1,2)

Department of Otolaryngology-Head and Neck Surgery, Michigan Medicine, Ann Arbor

Teresa A. Zwolan, PhD (2)

This article is intended to serve as a resource for clinicians to help keep up to date with current clinical literature and is intended for professionals only. Clinical literature is based on research, which may include the experimental use of new or currently available products and technologies. Therefore, literature presented on this blog may represent use of Cochlear products that does not align with the intended use or indications approved by regulatory bodies, also known as off-label use. Cochlear does not condone any off-label use of its products, and it is not Cochlear’s intent to promote off-label use by providing this blog as a resource to clinicians.

This content is meant for professional use. If you are a consumer, please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information. Views expressed are those of the individual. Consult your health professional to determine if you are a candidate for Cochlear technology.

All figures are our own.

For compatibility information and devices visit www.Cochlear.com/compatibility and resound.com/compatibility. For a list of compatible ReSound hearing aids visit www.Cochlear.com/nucleus/compatibility

Author

Cochlear Guest Author

In an effort to keep our content fresh and reflective of a diverse industry, Cochlear Americas features a mix of employees and professional partners to contribute to Cochlear ProNews as Guest Authors.

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Jolie Fainberg, AuD

How upgrade technology can lead to better hearing

January 12, 2021

By Jolie Fainberg, AuD, Cochlear Implant Program Director at Atlanta Institute for ENT

With 34 years of cochlear implant experience, Dr. Fainberg discusses upgrading patients to the latest Nucleus® Sound Processors.

What is your current role and what do you love about it?

I am an audiologist at a busy private ENT clinic in Atlanta, Georgia. We have a pediatric ENT, four adult ENTs and we just hired a neurotologist. I love my job because in the 29 years I have worked in Atlanta, I have watched hundreds of cochlear implant (CI) kids grow up. I get to follow them through their journey to develop hearing, speech and language – I become part of their family! Cochlear implants are the most exciting technology. There have been so many changes in this industry and it only gets better.

What do you consider the biggest changes in sound processor technology affecting your Cochlear™ Nucleus upgrade patients and why?

The addition of Bluetooth® streaming technology has had the biggest impact. Everyone loves to stream their music and have the convenience of using the phone directly to their CI. Nucleus Smart App is also a great addition. Patients have more control over their sound processor overall. They can make their own adjustments as needed and change programs more easily. Next, the Hearing Tracker and Find My Processor features have been lifesavers for many patients, particularly parents of young children.  Parents have found their kid’s CI in some pretty amusing places!

How has counseling your upgrade patients evolved with today’s sound processors?

I counsel my patients to really evaluate the benefits of a new sound processor prior to upgrading, as insurance companies have specific guidelines about approving upgrade. Insurance companies can be stricter about approving upgrades. Many require that the current sound processor is not functioning before they will approve the upgrade. This is challenging as I don’t want my patients to be without sound while we wait for approval.

The technology continues to improve in leaps and bounds. Although an upgrade to new sound processor can provide a smaller device, new technology options, etc., the real benefit is the improvement in hearing. I could be the best MAPping audiologist in the world, but there are limitations to technology that cannot be changed with MAPping. When new devices are released, the better sound quality and offer of better hearing transcends any MAPping changes I can make on old technology. I wish the insurance companies understood the hearing benefit our patients get when they upgrade. They might make it easier for patients to get new technology.

What features of the new sound processors do you feel improve hearing outcomes?

Here are a few features:

  • SCAN* (the industry’s first automatic scene classifier) has been beneficial to many of my CI users. For long term recipients, it takes a week or two for them to get used to it. After a period of adjustment, SCAN helps with changes in the hearing environment without having to adjust their CI.
  • Many of my patients have liked ForwardFocus** for restaurants and one-on-one conversations. 
  • I recommend the Mini Microphone 2+ for all my patients. It helps in so many situations such as the car, restaurants and college classes.
  • The Aqua+ wear options~ have been fun for many of my patients who have never been able to hear while swimming or playing in the water.

What are the biggest differences you’ve seen in your patients after an upgrade?

First and foremost: better hearing! I have dozens of stories where patients have heard things with their new sound processors that they never heard before. One patient told me that after she got her upgraded device and was walking with her dad to their car, she asked him: “What’s that sound?” He said, “I don’t hear anything.” They continued walking and then she realized, the sound was her footsteps. She had never heard them before. Another time, a young man received an upgrade after more than eight years and tearful at how clear the sound of the new sound processor was! The newer technology offers hearing that cannot be realized no matter what we do to an older device. That’s why we upgrade our phones and computers!

Would you highlight a success story about one of your earliest implanted Cochlear Nucleus 22 patient (adult and/or child)?

One of my N22 patients who was implanted at two years of age in 1992 just graduated from nursing school and works as a nurse. Because of the COVID precautions, she wears a mask all day at work. In addition, she is a unilateral CI user, as many of our early CI kids were only implanted on one side. She successfully navigates this difficult listening situation. I have a large number of N22 patients still using their original internal device successfully. These patients are all adults now and having a CI has not stopped them from doing whatever they wanted.

How do you counsel your patients on which Nucleus Sound Processor is right for them?

I show both options to my patients and review the highlights of each device. The decision between Nucleus 7 and Kanso® 2 is highly polarizing! Patients either want one or the other. Many of my patients who received their CIs very young do not want the drastic change from behind-the-ear to single unit sound processor. Other patients are really excited about getting a single unit CI and get the sound processor off their ear!

What have your patients been most excited about with the Kanso 2 Sound Processor?

They love the convenience of no cables or other parts to worry about. They like that the sound processor is off their ear. Many male recipients find it more aesthetically pleasing and less noticeable.

What innovations do you think will drive the CI industry forward?

In a post-COVID world, I think the capability to offer remote care like more complex remote programming will be in our future. The added benefit to this is the ability to offer better hearing healthcare services to patients living far away from a CI center.

Read more about upgrade technology here and watch this AudiologyOnline course!

About the author:

Jolie Fainberg is an audiologist with 36 years of experience. Her primary interests are pediatric audiology and cochlear implants for children and adults. She received her BA in Speech and Hearing Science at the University of California, Santa Barbara, her MA in Audiology at the University of Tennessee, Knoxville and her AuD from AT Still University. She participated on the original FDA clinical trials for all three cochlear implant companies. Her research has focused on pediatric audiology, pediatric cochlear implants, cochlear implants in special populations, diagnostic techniques for difficult to test infants and children, and brain plasticity in children. In 1992, she developed and established the pediatric audiology and cochlear implant program for Egleston Children’s Hospital at Emory University (now Children’s Healthcare of Atlanta).  She is a Clinical Instructor in the Department of Otolaryngology at the Emory School of Medicine and an Adjunct Professor at A. T. Still University Post Professional Doctor of Audiology program. Currently, she works at an ENT practice doing pediatric diagnostic testing and cochlear implants in adults and children.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cochlear is under license.

The Cochlear Nucleus Smart App is available on App Store and Google Play. For compatibility information visit www.cochlear.com/compatibility

*SNR-NR, WNR and SCAN are approved for use with any recipient ages six years and older, who is able to 1) complete objective speech perception testing in quiet  and in noise in order to determine and document  performance 2) report a preference for different program settings.

**ForwardFocus can only be enabled by a Hearing Implant Specialist. It should only be activated for users 12 years and older who are able to reliably provide  Feedback on sound quality and understand how to use the feature when moving to different or changing environments. It may be possible to have decreased speech understanding when using ForwardFocus in a quiet environment.

~The Nucleus 7 Sound Processor with Aqua+ is water resistant to level IP68 of the International Standard IEC60529. This water protection only applies when you use a Cochlear Standard Rechargeable Battery Module or Cochlear Compact Rechargeable Battery Module. The Kanso 2 Sound Processor is dust and water resistant to level of IP68 of the International Standard IEC60529. The Kanso 2 Sound Processor with Aqua+ is dust and water resistant to level of IP68 of the International Standard IEC60529. This water protection rating means that the sound processor with the Aqua+ can be continuously submerged under water to a depth of up to 3 meters (9 feet and 9 inches) for up to 2 hours. The Aqua+ accessory should be used when participating in prolonged water activities.

Dr. Bill Shapiro

Artificial Intelligence – Use in Hearing Healthcare by Bill Shapiro, AuD

December 4, 2018

Research updates

Bill Shapiro

 

By guest author: William H. Shapiro, AuD, CCC-A – Lester S. Miller, Jr and Kathleen V. Miller Clinical Assistant Professor of Hearing Health, Clinical Associate Professor in Otolaryngology, Supervising Audiologist, NYU Cochlear Implant Center

Artificial intelligence (AI) continues to change the way we live our lives. Gone are the days of traveling across country or even the city with a paper map in hand. Now we only need to tell our smartphones where we want to go and the friendly AI-powered avatar tells us when to turn and how long it will take to arrive at our destination. The same is soon to be true in our work lives as well.

As Brian Kaplan noted in a previous ProNews Blog, artificial intelligence has changed the way medical professionals are working and how they arrive at decisions; the same is true for hearing healthcare. However, the change is proving to be much slower than in other sectors of healthcare.

In 2005, Robert Margolis recounted the history of diagnostic tests in audiology and the how the profession has not kept pace with advanced technology. He quotes James Jerger, who in 1963, stated that most all of the routine audiometric tests conducted could be done by a machine while the audiologists would be consumed with analyzing and interpreting the results. Margolis summarized by stating, “My opinion is that if our profession does not embrace automated testing and drive the process of progress, other professions will do it for us.”1 Over a decade has passed since Margolis’ comments and automated audiometry is still not the standard of care for audiometrics but progress has been made in hearing aid technology.

In 2004, Oticon announced the first use of artificial intelligence in a decision-making feature that compared the outcomes of particular feature combinations to provide the optimal voice-to-noise ratio at any given minute2. This is an example of rapid comparison technology that provides options without taking advantage of a closed-loop machine learning technique.  Fourteen years later in April 2018, Widex introduced the first hearing aid which uses input from the patient via a smartphone app combined with real-life listening situations to employ machine learning to optimize the users hearing experience. Widex reports that the machine learning moves beyond simple decision-making to assist the individual by using data from around the world to benefit all Widex Evoke™ users through big data analysis3. This step in technological advancement encourages audiology to take advantage of more sophisticated artificial intelligence systems to better serve the patients who seek our help.

In a recent study at the University of Hong Kong and Ann & Robert Lurie Children’s Hospital of Chicago, AI has been employed in a novel way to predict language development in deaf children using cochlear implants. A machine-learning algorithm used pre-cochlear implant surgery MRI scans to detect abnormal brain development with a high degree of accuracy, specificity and sensitivity. This provided clinicians with information about how to personalize post-surgery habilitation efforts to help those children develop language skills4. AI provides promise in helping predict outcomes according to this study and AI can also be used to standardize and streamline cochlear implant fittings.

Currently, a clinical study in the United States employs an artificial intelligence engine to help standardize cochlear implant programming through a direct-connect system. Cochlear has licensed technology from Prof. Paul Govaerts of Belgium to evaluate recipient outcomes and clinician and recipient acceptance of a new AI technology. The AI system utilizes a closed-loop system of evaluation measures to provide outcome-driven fitting recommendations based on the test measures in a standardized approach to post-operative cochlear implant programming. The software test module may allow for improved clinician and recipient experience by allowing the testing to be delivered directly to the recipient’s sound processor outside of a test booth.  The AI system provides several options to potentially improve outcomes, based on data across major cochlear implant systems and individual psychoacoustic test measures. These AI recommendations come from comparisons to millions of MAPs and parameter settings which could substantially increase the chances of optimized outcomes while reducing programming time for the recipient and the clinician. Additionally, this evidence-based programming method could provide consistency in programming, outcomes and experience for the recipient whether they see a novice or experienced clinicians.

Hearing aid fittings have used real-ear targets for decades, now we are studying the AI technology to develop target-based fittings in cochlear implants as well. This exciting step into advanced AI use can help move our profession to provide the evidence needed to convince audiologists to try another tool in the toolbox of CI fittings. We are not looking to have an AI-assisted avatar tell us how to program, but as our industry grows and provides services to more patients, we do need to continue to standardize the way we provide cochlear implant technology so that more patients obtain optimal results.

See the references below for more information.

About out guest author:

William H. Shapiro received his Master of Arts degree in Audiology from Queens College of the CUNY in 1978. He received his Doctorate of Audiology from Arizona School of Health Sciences, A.T. Still University in 2007. He has worked at New York University since 1984 where he has been involved with all aspects of diagnostic and rehabilitative audiology, including the dispensing of assistive hearing technology (hearing aids, FM systems). He currently holds the title, Lester S. Miller, Jr.& Kathleen V. Miller Clinical Assistant Professor of Hearing Health, in the Department of Otolaryngology, is Director of FGP Audiology, and is Supervising Audiologist at the New York University Cochlear Implant Center, a nationally recognized center of excellence in the field of cochlear implants. Dr Shapiro has several publications in peer reviewed journals as well as book chapters. He has presented at conventions, both nationally, as well as internationally. He serves on the advisory board of two cochlear implant manufacturers. He is the 2008 recipient of the “Outstanding Clinician Award” received from the New York State Speech, Language and Hearing Association.

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  1. Margolis, R (2005) “Automated Audiometry: Progress or Pariah?” whitepaper prepared for AudiologyOnline.
  2. Schum, D. (June 2004) “Artificial Intelligence: The New Advanced Technology in Hearing Aids”, AudiologyOnline, https://www.audiologyonline.com/articles/artificial-intelligence-new-advanced-technology-1082.
  3. April 2018, “Widex Launches the World’s First Machine Learning Hearing Aids”, press release, https://global.widex.com/en/news/widex-launches-worlds-first-machine-learning-hearing-aid-evoke.
  4. Ann & Robert H. Lurie Children’s Hospital of Chicago. (2018, January 15). Brain imaging predicts language learning in deaf children. ScienceDaily. Retrieved August 6, 2018 from sciencedaily.com/releases/2018/01/180115151559.htm
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This material is intended for health professionals. If you are a consumer, please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

 

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